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This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices. [ABSTRACT FROM AUTHOR]

Key Points: Question: When medical devices that had been cleared under the FDA's 510(k) pathway are subject to Class I recalls, how often did the predicates for these devices also have a history of recalls? Findings: In this cross-sectional analysis of 156 cases of 510(k)–authorized devices with Class I recalls from 2017 through 2021, 44.1% used predicates with Class I recalls. In addition, 48.1% of these devices were subsequently used as predicates to authorize descendant devices later subject to Class I recalls. The risk of a Class I recall was 6.40 times higher for descendants that used predicates with Class I recalls than for devices using Class I recall–free predicates. Meaning: Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety. Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall—the FDA's most serious designation indicating a high probability of adverse health consequences or death—as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety. This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall. [ABSTRACT FROM AUTHOR]

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed. [ABSTRACT FROM AUTHOR]

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice.Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017.Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only.Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding.Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI.Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients. [ABSTRACT FROM AUTHOR]

Importance: High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements.Objective: To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data).Design and Setting: Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015.Exposure: Panel-track supplement approval.Main Outcomes and Measures: Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex.Results: Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements.Conclusions and Relevance: Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved. [ABSTRACT FROM AUTHOR]

This study uses National Inpatient Sample data to characterize trends in transcatheter aortic valve replacement (TAVR) in age groups 55 years and older in the United States from 2012 to 2015. [ABSTRACT FROM AUTHOR]

The article discusses a study which investigated premarket approval (PMA) of cardiovascular devices by the U.S. Food and Drug Administration (FDA). The study also attempted to characterize the type and strength of evidence of which the FDA review process is based. The authors systematically reviewed summaries of safety and effectiveness data for 78 PMA for high-risk cardiovascular devices approved between January 2000 and December 2007. They concluded that premarket approval was often based on studies that lack adequate strength and may be prone to bias.

This Viewpoint reviews the FDA's 510(k) premarket review pathway through which many medical devices are brought into the US market based on "substantial equivalence" to a currently available device and the FDA's 2019 guidance for an alternative "Safety and Performance Based Pathway," and proposes additional strategies and policies to reduce harms from 510(k) approval mechanism and improve the safety and effectiveness of medical devices. [ABSTRACT FROM AUTHOR]

The article discuses the study on high-risk cardiovascular device regarding the presence of comparative effectiveness data during the premarket approval of the devices by the approving agencies. It mentions the use of control data from previous report during the device trials, and highlights the importance of the test data of devices relating its selection bias and validity. It informs the methodology involving the extraction of data from the U.S. Food & Drug Administration (FDA) related to safety and effectiveness, and emphasis on the examination of the primary end points regarding the determination of type of controls used for the comparison of the device. INSET: Box. Coding of Studies and Primary End Points.

A letter to the editor is presented in response to the article "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices," by S. S. Dhruva and colleagues in the 2009 issue, along with a response from the authors of the article.

The author discusses the draft guidance released by the U.S. Food and Drug Administration in December 2011, which talks about the underrepresentation of women in medical device clinical trials and offers recommendations for ensuring adequate enrollment of women in these trials. He comments on the National Institute of Health's experience with gender bias guidances which indicates the importance of enforcement, tracking and consequences for noncompliance.

A letter to the editor is presented in response to the article "When Separate Is More Equal," by N. E. Adler in a 2010 issue, as well as a response from the author of the article.

Letters to the editor are presented in response to the article "Accelerated approval and possible withdrawal midodrine," by S.S. Dhruva and colleagues published in a 2010 issue.

The authors reflect on the accelerated market approval experienced by the α-1 adrenergic agonist midodrine hydrochloride and its possible market withdrawal in 2010. They note that the drug was approved for the treatment of symptomatic orthostatic hypotension with the guarantee that the drug's sponsor would complete postmarketing studies to demonstrate clinical benefit. They reveal that since the drug's accelerated approval in 1996, the initial sponsor of the drug only conducted 1 randomized trial of 24 patients, which revealed no benefit.